NCT04494568 (ENDO-HIFU-R1) is a NA clinical trial of HIFU treatment in Endometriosis, Rectum, sponsored by EDAP TMS S.A..

Who is sponsoring NCT04494568?

NCT04494568 is sponsored by EDAP TMS S.A..

What drugs are being tested in NCT04494568?

Interventions in NCT04494568: HIFU treatment.

What condition does NCT04494568 study?

NCT04494568 studies Endometriosis, Rectum.

Is NCT04494568 still recruiting?

NCT04494568 is currently completed. Last updated 1 February 2023.

Last reviewed 2023-02-01 · How we verify

NCT04494568: ENDO-HIFU-R1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis

Completed NA Last updated 1 February 2023

What this trial tests

NA trial testing HIFU treatment in Endometriosis, Rectum in 60 participants. Completed in 30 November 2022.

Timeline

27 August 2020

Primary endpoint
1 November 2022

30 November 2022

Quick facts

Lead sponsor	EDAP TMS S.A.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	27 August 2020
Primary completion	1 November 2022
Estimated completion	30 November 2022
Sites	5 locations across France

Drugs / interventions tested

HIFU treatment

Conditions studied

Endometriosis, Rectum — all drugs for Endometriosis, Rectum →

Sponsor

EDAP TMS S.A.

Who can join

25 and older, female only, with Endometriosis, Rectum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative procedure using a high-intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation. Focal One® is a transrectal HIFU device, which is validated to treat prostatic cancer. The primary objective of this clinical investigation is to evaluate the safety of the HIFU treatment of rectal endometriosis with Focal One® HIFU device.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of HIFU treatment

Trials testing the same drug.

NCT07461064 — HIFU vs Observation for LSIL of Cervix: A Randomized Controlled Trial · NA · not yet recruiting
NCT04853914 — Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound. · NA · completed
NCT02246504 — Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules. · NA · completed

Other recruiting trials for Endometriosis, Rectum

Currently open trials in the same condition.

NCT04204707 — Patient Reported Outcomes After Surgery for Rectal Endometriosis · active not recruiting

Other EDAP TMS S.A. trials

Trials by the same sponsor.

NCT06601179 — Evaluating the Safety and Efficacy of the "HIFU" High-intensity Focused Ultrasound Treatment of Benign Prostatic Hyperpl · NA · recruiting
NCT06375629 — ES-HIFU, Prospective Data Collection of Patients Treated With Partial Gland HIFU Ablation for Prostate Cancer · terminated
NCT05755958 — Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms. · NA · active not recruiting
NCT07179419 — Evaluation of the Long-term Therapeutic Effect of High-Intensity Focused Ultrasound (HIFU) Treatment in Patients With Re · recruiting
NCT04853914 — Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound. · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04494568 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by EDAP TMS S.A.
Last refreshed: 1 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04494568.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing